NCT05965128

Brief Summary

Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and realizes real-time monitoring and early warning of acute respiratory infectious diseases in Shanghai.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,255

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 20, 2023

Last Update Submit

July 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • the detectioin rate of pathogenic microorganism in each step

    the detectioin rate of pathogenic microorganism in each step

    48 hours

Secondary Outcomes (2)

  • hospitalization rate

    48 hours

  • rate of critical illness

    48 hours

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

this study enrolled patients who were admitted to the fever clinics and emergency room for influenza-like illness or pneumonia and pathogenic detection was necessary for clincial diagnosis and treatment.

You may qualify if:

  • Acute onset within one week;
  • years old;
  • Present with pneumonia (present with pulmonary signs or radiological changes) or influenza-like illness (including the following symptoms: sudden onset of fever (\>38 ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one or more systemic symptoms (fatigue, headache ect.))

You may not qualify if:

  • Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder or mental problem.
  • Patients with psycological problem or unconsciousness who cannot tell the disease history and cooperate with medical examinations;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

NOT YET RECRUITING

Heilongjiang Provincial Hospital

Harbin, Heilongjinag, 1500036, China

NOT YET RECRUITING

People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

NOT YET RECRUITING

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

NOT YET RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

NOT YET RECRUITING

Shenyang Sixth People's Hospital

Shenyang, Liaoning, China

NOT YET RECRUITING

Shandong University Qilu Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Jining Public Health Center

Jining, Shandong, 0537-7970121, China

NOT YET RECRUITING

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

NOT YET RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

NOT YET RECRUITING

Ruian City People's Hospital

Rui’an, Zhejiang, China

NOT YET RECRUITING

Central Study Contacts

Wenhong Zhang, M.D.

CONTACT

Jingwen Ai, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Division of Infectious Diseases

Study Record Dates

First Submitted

July 20, 2023

First Posted

July 28, 2023

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2027

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations